Senior Clinical Data Manager (Remote - US)

About the role

MMS is an award-winning, data-focused clinical research organization (CRO) supporting the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains an industry-leading customer satisfaction rating and fosters a collaborative, inclusive work environment where employees can thrive. As a Great Place to Work certified organization, MMS is recognized for its exceptional culture and best-in-industry employee retention.

Responsibilities

• Display excellent internal and external customer service
• Apply proficiency in multiple EDC systems to advise customers on best-fit solutions
• Interact directly and independently with data management (DM) suppliers, including EDC and/or IWR, as an expert communicator; negotiate with suppliers to meet business needs
• Coordinate all facets of projects through direct, independent interaction with clients; build and maintain strong client relationships
• Serve as primary contact for the entire data management process, from study set-up to close-out, including resolution of study-specific issues; demonstrate high-level knowledge of drug development as it pertains to data management
• Actively participate in protocol review with clients, providing suggestions for successful database capture of protocol information
• Maintain a strong understanding of GCP/ICH guidelines and FDA regulations applicable to data management
• Create training exercises; mentor and train new clinical data managers
• Provide oversight and resolve issues in data management study processing activities, including CRF tracking, data entry, integration of external electronic data (e.g., lab data), data validation and review, query processing, adverse event and medication coding, SAE reconciliation, database lock, and QC audits
• Oversee and develop data management study documentation, including Case Report Forms (CRFs), CRF Completion Guidelines, Database Design via annotated CRFs, Validation specifications (edit checks), and Data Management Plans
• Prepare study tracking and metric reports for the study team
• Oversee execution of user acceptance testing (UAT) for study-specific systems and applications
• Collaborate with cross-functional team members to ensure timely completion of studies
• Participate in data management and/or organizational initiatives
• Initiate SOP updates and provide specifications for DM systems, tools, and process enhancements
• Act as a resource for QC activities in collaboration with the QC Coordinator
• Follow project management processes for data management projects (e.g., updating PSS, close-out procedures)
• Maintain a confident, positive attitude toward clients and projects
• Demonstrate willingness to learn new skills and expand knowledge of drug development
• Lead data management projects with minimal management oversight; work independently to resolve issues
• Clearly articulate MMS’s DM services, including pros and cons of various DM approaches, and represent the company in capabilities and bid defense meetings (web or remote)

Requirements

• Bachelor’s or Master’s Degree in a scientific or healthcare field preferred, with industry or relevant experience
• 5+ years of experience in the data management field, with a minimum of 1 year leading projects
• Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems
• Extensive knowledge of Clinical Operations SOPs and Working Practices
• Excellent verbal and written communication skills, as well as strong interpersonal and organizational skills